BD PhaSeal 515104Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382905151040), received between Apr 2, 2019 and Mar 13, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 16, 2025Open, Classified

   Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.

   Z-2453-2025 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A SMALL PIECE OF GRAY "RUBBER" WAS SEEN IN THE "LIQUID/MEROPENEM" VIAL ATTACHED TO THE PROTECTOR P28 DURING USE, AND NEW ANTIBIOTICS HAD TO BE USED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE PROTECTOR (P28) VIAL ADAPTER WAS ATTACHED TO THE VIAL, THE NURSE SPOTTED, THAT THERE WAS A PIECE OF RUBBER IN THE LIQUID/MEROPENEM VIAL. A SMALL PIECE OF GREY SOMETHING, LOOKING LIKE IT WAS FROM THE TOP OF THE VIAL? THE NURSE PUTTED THE PRODUCT AWAY, AND STARTED OVER WITH A NEW VIAL AND NEW PHASEAL PTOTECTOR" "NEEDED TO OPEN A NEW BOTTLE OF ANTIBIOTICS".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9831614 ↗
• MalfunctionFeb 26, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PROTECTOR P28 HAD FOREIGN MATTER IN THE VIAL. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE PROTECTOR (P28) VIAL ADAPTER WAS ATTACHED TO THE VIAL, THE NURSE SPOTTED, THAT THERE WAS A PIECE OF RUBBER IN THE LIQUID/MEROPENEM VIAL. A SMALL PIECE OF GREY SOMETHING, LOOKING LIKE IT WAS FROM THE THE TOP OF THE VIAL? THE NURSE PUT THE PRODUCT AWAY, AND STARTED OVER WITH A NEW VIAL AND NEW PHASEAL PROTECTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9759098 ↗
• MalfunctionJan 29, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT LEAKAGE OCCURRED BETWEEN THE PROTECTOR AND VIAL WITH A BD PHASEAL¿ PROTECTOR P28. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT A LEAK OCCURRED BETWEEN THE PROTECTOR AND THE VIAL. ADDITIONAL INFORMATION PROVIDED 2020-01-16: Q: - THE INVESTIGATION TEAM WOULD LIKE TO KNOW HOW THE PROTECTOR WAS ATTACHED TO THE VIAL: WAS IT PLACED MANUALLY ON THE VIAL OR WAS THE PHASEAL ASSEMBLY FIXTURE BEING USED? A: - THE DEVICE WAS PLACED MANUALLY BY THE COMPOUNDING TECHNICIAN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9641029 ↗
• MalfunctionApr 2, 2019Leak/Splash

  IT WAS REPORTED THAT DRUG WAS SPRAYED DURING MIXING WITH A BD PROTECTOR P28¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHASEAL PROTECTOR (P28) WHICH SPRAYED DRUG ALL OVER, DURING MIXING, AND WE HAD TO WASTE A VIAL OF THAT DRUG. THE COMPOUNDING TECHNICIAN ATTACHED THE VIAL PROTECTOR, AND THEN WHEN THEY BEGAN TO ATTACH THE SYRINGE ADAPTER AND INSERT THE NEEDLE/ FULLY CONNECT THE ADAPTER THE DRUG STARTED SPRAYING OUT OF THE VIAL WHERE THE CONNECTION WAS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8476279 ↗